Baylor College of Medicine

Ethicists: access needed after brain implant clinical trials

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Dr. Gabriel Lazaro-Munoz, assistant professor in the Center for Medical Ethics and Health Policy at Baylor

Spurred by significant investment by the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, next generation deep brain stimulation (DBS) and other brain implants are gaining momentum in clinical trials to treat serious treatment-resistant brain-related conditions. In new research from Baylor College of Medicine, the ethical questions surrounding what happens to trial participants when these trials end are examined. The study appears in Nature Reviews Neuroscience.

“Generally, there are no funds to let the participants access the intervention after the trial is over,” said Dr. Gabriel Lazaro-Munoz, assistant professor in the Center for Medical Ethics and Health Policy at Baylor. “Deep brain stimulation and other brain implants could help manage serious conditions, such as depression. However, after the trial, most participants cannot afford to keep the device functioning and therefore no longer experience the benefits.”

The research team wanted to provide an ethical justification for why participants who benefit from these trials should have some assistance to keep their brain implant functioning after the trial is over.

“The participants will likely revert to the debilitating symptoms they were suffering from before the trial started because it is cost prohibitive for most participants to continue the intervention,” Lazaro-Munoz said.

This study reveals a need to find a way to work with patients, physicians, researchers, insurance companies, government and private sponsors, and regulatory agencies to develop guidelines to better manage the issue of access to care following clinical trials. Lazaro-Munoz and colleagues also hope the study will start a conversation about solutions and funding options and will inspire action from stakeholders to address this issue seriously for the benefit of the patients.

“Not only do guidelines for post-trial access to brain implants need to be further developed, but they also need to be actively enforced,” said Lazaro-Munoz. “Creating concrete guidelines that balance the interests of all stakeholders will help advance this research and promote the responsible translation of these technologies into clinical care.”

Other contributors to this work include Drs. Daniel Yoshor, Michael Beauchamp, Wayne Goodman and Amy McGuire, all with Baylor. This research was funded by the US National Institute of Mental Health, the US National Eye Institute and the US National Institute of Neurological Disorders and Stroke.

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